Past, present, and future of robotic surgery for endometriosis and hysterectomyVladimir Nikifarouk, MD

Hi, I know it is already 3:00 and everybody wants to go home but I was doing one presentation and my little one, an 11 year old, wanted to be involved in that. So I had to rethink how would I talk so that an 11 year old would understand? The point of this conference is patient education, doctor education and I wanted to combine and sort of resolve a little controversy about the robot. You guys just started exactly what I was planning to talk about and you are almost finished.

My daughter put this slide in. It says “who needs surgery in space”? For people who do not know this robotic technology was developed or idea of robotic surgery was developed by NASA trying to invent something that in case an astronaut would need to have surgery, he or she will safely be brought to space. So it sounds great, yes? But apparently someone else has to put the probes in space so it does not work.

Then the army decided to take this idea a go a little bit further at the same time. It was a great idea but at least the surgeon and the patient would not be in space and hopefully a surgeon can come to the patient in time when a robot does not work.

That is how I felt the first time I listened that surgery can be done by a robot. I was completely shocked, pessimistic and a little bit upset because I learned so much to be a great or good laparoscopist and now a robot was going to do surgery for me. So where is the glory for me?

The first case, the first time the FDA approved robotic surgery was not that long ago. It was just ten years ago. The first time I heard it was 2006 when Intuitive reps came to my hospital trying to sell the robot. I just want to say how much it cost. It is approximately $2 million for the hospital to acquire that beautiful machine but it is not only that, it is also $300,000 a year maintenance of that beautiful machine. On top of that you have to buy new instruments every tenth time you use it.

So what happened from 2005 - Intuitive strategy. They invested a lot of money to build that technology so they aggressively marketed it to hospitals, aggressive doctors were recruited, aggressive media marketing to the patients and as a result of that beautiful business strategy they sold, I would say, probably about 2000+ robots in the United States and worldwide. The rate of hysterectomies as a major surgery went from 2500 just in 2007 to almost 50,000 in 2010 so I do not know the data now but it is growing rapidly. Then around two or three years ago and everybody started to panic because of what happened - surgery lawsuits. They created a demand for their procedure but the training of the doctors who use this machine was not good enough. A lot of doctors in the beginning especially went for one day observation, couple of hours on the console and they called them robotic surgeons. They took patients for major surgery using major and most complex machine that probably exists on earth now.

Currently, the Intuitive Company decided to have some kind of regulations of how to bring a doctor from being a generalist to being an advanced robotic surgeon. They have 20 hours on a modulator, you simply play games on a computer and you see if you can put coins from one cup to another using the arms of the robot. Then you have to pass a little multiple choice test, then they take you for one day in an animal lab that you operate on an animal – that is a couple of cases. And of course when you start to do it in a hospital they will bring a proctor for five cases, and of course here is another cost. It is $3000 per case for the proctor. It is another $15,000 investment in education.

Finally, recently, probably just a few months ago the AAGL came up with a statement based on a very big controversy about robotic versus laparoscopic and traditional surgery. The recommendation was that surgeons must be selected but it does not say how. Practice makes perfect so they recommend the doctor that uses a robot has to have a specific amount of cases a year so they keep their skills. Also the surgeon should be able to demonstrate their competency in the OR but nobody said how to do it. So the idea is outlined but we still do not know what to do. Just a few days ago I was doing research on this topic to see what was new, what was interesting that I could come up with for this presentation and I found actually the most important slide you will see here. And that is actually for the patients to take home – a message.

ACOG, the American College of Gynecologists, and SGS, Society of Gynecologic Surgeons , that my mentor actually founded that society, Dr…who trained me all these years before. They combined and came up with a committee opinion, which states that more research needs to be done because of the controversy of what is better, robot or laparoscopy. Who benefits better? We do not have research There are different articles that say okay robotic surgery is great, much better than laparoscopy and other research says the opposite and another research says there is no difference in the two ways of how to perform surgery.

The second one, which I really like, doctors have to take in consideration who is going to benefit? Why are we doing surgery? Am I benefitting by doing tubal ligation using the robot, or the patient benefits? Doctor training, there are no outlines who that has to be and what are a good amount of cases, what is a good technique to evaluate the doctor, is it good or not, good training or not?

Another one, which I love and I am going to say one more time, is adequate consent given. What it means is that the patient really needs to know what they are signing up for. What are the benefits? Who is doing it? And what I love is disclosure of the surgeon experience. The patients should ask the doctor who is going to sell them that beautiful surgery and dream of being operated on by a robot. “How many cases have you done doctor?” “Oh, this is my first case”. Do you want to go and be the first one or not? Also they recommend developing a registry so there is no organization or anyone in the United States or worldwide who can monitor outcomes, cases, number of cases, performance of surgeons, performance of machines. That somebody has to work on and develop it. That is what we are dealing with today.

Let us talk about the future. What is next? I do not know. Anybody know what is going to happen with the robot? No? But one thing I am going to tell you. Robotic surgery is here, it is staying here and not going anywhere. In my opinion, and again you are probably going to ask questions but we have already talk about that. In my opinion, and it is just my opinion, advanced laparoscopic training and skill must be required prior to robotic surgery. I do not want, and I do not feel right that the surgeon who was trained in 1973 and never did laparoscopic surgery in 2015 got to sit at a console and operate that machine. It is not only just laparoscopic it has to be advanced laparoscopic skills. I am going to tell you why. Because I had cases that I started robotically and I evaluated the situation and I thought “oh my gosh I have to open” but I said “you know what, I will I take the stick, I will take instruments and I will do it laparoscopically and I will make it possible to continue robotically. In case you have skills like that you will prevent and patients will benefit from being open for no reason.

Extensive training in open and vaginal approach also has to be done. What I mean by that is there are situations that you really need to convert the case to open. If you have not been trained in a good residency program for years and you have done three open hysterectomies that can be a little challenging problem.

Monitoring skills and outcomes and volume of the surgery – I hope we would have a committee, robotic committee that would require doctors who want to have privileges to submit videos, abstracts, volume and I would love if organizations like the AAGL would have a committee come in and observe live surgery with the people who require these kinds of privileges.

And one that is very, very short, reducing the cost of the Da Vinci instruments. That is the marketing that they have. They want to make money and as I said at the beginning it is $300,000 per hospital so you have a robot for ten years and it is $3 million on top of the machine that you bought. In five years they will come with a new robot and they will want you to buy another one. The instruments are reusable but I think you can reuse them way more than ten times - they are programmed with a chip that after ten times of use they stop working. The good news on the horizon Intuitive is the only company right now in the world that FDA approved it has full function and Da Vinci robot. But for people who want to make money and invest there are a few other companies that are at end stages of developing competition. I just hope they will develop an adequate, good robot and robotic systems that can compete with Intuitive and the cost of surgery will go down. The patients will benefit, it will be more affordable for the hospital to maintain and have it and for patients to have access to this great technology.

Thank you.

Harry Reich, MD: I just have a couple of questions. First of all I think it is very impressive that you gave a talk without showing a lot of video. Because I have seen you operate and he is in another world. How long do you do the hysterectomies in?

Vladimir Nikiforouk, MD: My hospital and like I said, we perfected it. A trick of my program is several things. We have four doctors who perform robotic surgery. We are extremely demanding and we like everything perfect. I do not have patients at all. I cannot wait for changing of room, I cannot stand an incompetent assistant and we created a system that I have the same PA, I have the same assistant that is going to manipulate the uterus below. I have one, the same, circulating nurse and we have another scrub nurse. If someone goes on vacation it becomes a problem because we have to get someone else. Then if they know all of that from the moment the patient is asleep and robot is attached it takes us probably seven minutes. Docking the robot is a big waste of time that groups have.

Harry Reich, MD: But you change fast.

Vladimir Nikiforouk, MD: Yes, they change very fast. Then I put the probes then I can go and have a sip of coffee, answer a call, my assistant already has everything done, it takes probably three to four minutes to do it. After that they know exactly and they read my mind. I do not have a resident that I have to teach “stop, don’t do it” you know, “turn left” but they turn right. My team knows and usually I love to talk and we all like to joke before. But during the time I am on the console I concentrate and there is no distraction in my room. And they know exactly what I am going to do. There is sort of a telepathy developed.

Audience Member: What procedures do you use a robot for?

Vladimir Nikiforouk, MD: I do everything but you know I do not do simple things like tubal ligation I do not do that. Cystectomy I can do with a scope. (Audience Member: So everything is…) I have a lot of patients that have already seen several doctors.

Another interesting issue that we have with rate of hysterectomy is 35 to 40 percent repeat hysterectomies two, three, four times you really do not know what you get inside. The scarring from a C-section is sometimes worse than endometriosis. Endometriosis is a perfect, magnificent surgery that robot can benefit. But, many, many times I use the robot for enlarged uterus 15, 16 17 weeks helps me to save opening the patient – saves time. My patients go home the same day. In three or four hours they go home on Motrin.

Audience Member: Do you think the average gynecologist has enough volume to…

Vladimir Nikiforouk, MD: The average gynecologist has seven surgeries a year, seven hysterectomies a year. I would go to any of you guys to have my hysterectomy but what about other people who do not know how to choose a doctor?

Harry Reich, MD: How many do you do would you say in a year?

Vladimir Nikiforouk, MD: Easily close to 100 major cases you use the robot.

Audience Member: So it is not feasible for the average gynecologist to be a robotics surgeon.

Vladimir Nikiforouk, MD: We got lucky being in the right location that we have a lot of neglected population that for years there was no good…service. Now we still have them coming and coming by word of mouth. That is the best.

Harry Reich, MD: In northeastern Pennsylvania there are, he is in Stroudsburg, you would have to go an hour and a half to Allentown, Bethlehem area or an hour to the Woodsburgh area. In Scranton there is nobody. There is a medical school there though.

John Dulemba, MD: I think we mentioned it before but you mentioned extensive training in open and in vaginal approach and advanced laparoscopic training. As you said a regular gynecologist are not going to be able to do a lot of that. They just cannot.

Vladimir Nikiforouk, MD: No, we just have a minimally invasive fellowship.

John Dulemba, MD: No, but not everybody can go to a fellowship. We are talking about somebody in Scranton. We are talking about somebody in Denton. We are talking about somebody anywhere that is going to try and do laparoscopic surgery and they are going to have a hard time. They can have less of a hard time with robotic surgery. But if you try to do it all, you try to do vaginal, you try to do open, you try to do laparoscopic, you try to do robotic, come on! They are not going to get good at anything!

Vladimir Nikiforouk, MD: What I meant is that experience never goes away. If you have good experience in laparoscopy, open or vaginal it always can come and be used when you are doing robotic.

Audience Member: It sounds like you said, and maybe I misunderstood you (talking to John Dulemba, MD) you are saying that if you are not that good at laparoscopy you could be good at the robot?

John Dulembba, MD: Sure you are.

Audience Member: I think that is not a good thing to say.

John Dulemba, MD: (Not clear.)

Harry Reich, MD: The company, the greedy company decided that urology is where it is really indicated because many people when they do the prostate have trouble sewing the bladder to the urethra and they figured “look there are all these hysterectomies being done with open”. So their next step was to gravitate to…

Vladimir Nikiforouk, MD: General surgery now. Now in my hospital we do gall bladders. It takes them five hours to do gall bladders. Laparoscopically they can do it in 30 minutes. They do robotic hernia repairs.

John Dulemba, MD: Wait, wait, wait, when they started doing laparoscopic gall bladders and how many hours did they take?

Harry Reich, MD: Wait, I did the first four laparoscopic gall bladders in this hospital in 199_

John Dulemba, MD: And how long did they take?

Harry Reich, MD: Thirty minutes.

John Dulemba, MD: Our general surgeons were taking four to five hours laparoscopically.

Harry Reich, MD: I did four in one day.

Vladimir Nikiforouk, MD: It is a good topic, it is controversial.

Tamer Seckin, MD: Thank you, it was a great presentation. I really think there is a place for robotics in the laparoscopic surgical world. It is just that my heart does not allow me to put those robotic instruments into a 16-year-old kid’s belly. They are big, they are multiple. The ones that I am seeing – last week I saw three post-robotic surgeries in my office, I am telling you, I did not even bother showing today. It is like the human pelvis is a new battle zone for endometriosis treatment. It is going like everybody is trying to do things and people are coming back with terrible results. But they are not as experienced as you are but unfortunately there is a license to do anything they want when they do the robot. It is like the early days of laparoscopic surgery. I see the videos that come to me. It is not nice. It is really not. It is a shame and these, I think the company should train these people to do meticulous surgery that they are advertising because meticulous surgery is not there. Robot does not mean that – robot could be as good as you are. It is not going to cover your inept or anybody’s inept technique. A computer does not help if you do not have the move.

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